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DELFLEX
Overview
What is DELFLEX?
The DELFLEX
peritoneal dialysis solutions (standard and low magnesium/low calcium) are sterile, non-pyrogenic formulations of dextrose and electrolytes in water for injection, USP, for use in peritoneal dialysis. These solutions do not contain antimicrobial agents or additional buffers. Composition, calculated osmolarity, pH, and ionic concentrations are shown in
.
Dextrose, USP, is chemically designated D-glucose monohydrate (C
H
O
•H
O) a hexose sugar freely soluble in water. The structural formula is shown here:
Calcium chloride, USP, is chemically designated calcium chloride dihydrate (CaCl
•2H
O) white fragments or granules freely soluble in water.
Magnesium chloride, USP, is chemically designated magnesium chloride hexahydrate (MgCl
•6H
O) colorless flakes or crystals very soluble in water.
Sodium lactate Solution, USP, is chemically designated (CH
CH(OH)COONa), a 60% aqueous solution miscible in water.
Sodium chloride, USP, is chemically designated (NaCl), a white, crystalline compound freely soluble in water.
Water for injection, USP, is chemically designated (H
O).
Hydrochloric Acid or Sodium Hydroxide may be added for pH adjustment. pH is 5.5 ± 0.5.
Exposure to temperatures above 25°C (77°F) during transport and storage will lead to minor losses in moisture content. Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period. Since the flexible inner bag is compounded from a specific polyvinyl chloride, water may permeate from the inner bag into the outerwrap in quantities insufficient to affect the solution significantly. Solutions in contact with the plastic inner bag can cause certain chemical components of the bag to leach out in very small amounts; however, the safety of the plastic formulation is supported by biological tests for plastic containers.
Table 1. Composition, Calculated Osmolarity, pH, and Ionic Concentration
What does DELFLEX look like?
What are the available doses of DELFLEX?
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What should I talk to my health care provider before I take DELFLEX?
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How should I use DELFLEX?
DELFLEX
peritoneal dialysis solutions are indicated in the treatment of chronic renal failure patients being maintained on peritoneal dialysis when nondialytic medical therapy is judged to be inadequate.
DELFLEX
peritoneal dialysis solutions are provided for intraperitoneal administration only. The mode of therapy, frequency of treatment, formulation, exchange volume, duration of dwell, and length of dialysis should be selected by the physician responsible for the treatment of the individual patient.
To avoid the risk of severe dehydration or hypovolemia and to minimize the loss of protein, it is advisable to select the peritoneal dialysis solution with lowest level of osmolarity consistent with the fluid removal requirements for that exchange.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.
Additives may be incompatible. Please refer to manufacturer’s product insert. Do not store solutions containing additives.
For administration see
section.
What interacts with DELFLEX?
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What are the warnings of DELFLEX?
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What are the precautions of DELFLEX?
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What are the side effects of DELFLEX?
Sorry No records found
What should I look out for while using DELFLEX?
None known.
Not for Intravenous Injection.
Use Aseptic Technique.
After removing the outerwrap, check for minute leaks by squeezing the solution bag firmly. If leaks are found, discard the solution because the sterility may be impaired. (A small amount of moisture may be present inside the outerwrap, which is normal condensation from the sterilization process).
Peritoneal dialysis should be done with great care, in patients with a number of conditions, including disruption of the peritoneal membrane or diaphragm by surgery or trauma, extensive adhesions, bowel distention, undiagnosed abdominal disease, abdominal wall infection, hernias or burns, fecal fistula or colostomy, tense ascites, obesity, large polycystic kidneys, recent aortic graft replacement, lactic acidosis and severe pulmonary disease. When assessing peritoneal dialysis as the mode of therapy in such extreme situations, the benefits to the patient must be weighed against the possible complications.
Solutions containing lactate ion should be used with great care in patients with metabolic or respiratory alkalosis. Lactate should be administered with great care in those conditions in which there is an increased level or an impaired utilization of this ion, such as severe hepatic insufficiency.
An accurate fluid balance record must be kept and the weight of the patient carefully monitored to avoid over or under hydration with severe consequences, including congestive heart failure, volume depletion and shock.
Excessive use of DELFLEX
peritoneal dialysis solution with 4.25% dextrose during a peritoneal dialysis treatment can result in significant removal of water from the patient.
Stable patients undergoing maintenance peritoneal dialysis should have routine periodic evaluation of blood chemistries and hematologic factors, as well as other indicators of patient status.
Serum calcium levels in patients using low calcium concentrations should be monitored and if found to be low, the peritoneal solution in use should be altered to one with a higher calcium concentration.
What might happen if I take too much DELFLEX?
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How should I store and handle DELFLEX?
Store at 20°C to 25°C (68°F to 77°F) [See USP controlled room temperature]. Protect from moisture.DELFLEX peritoneal dialysis solutions are delivered in single-dose flexible bags. All DELFLEX peritoneal dialysis solutions have overfills declared on the bag label. The flexible bag has the capacity for drainage in excess of their stated fill volume for ultrafiltration from the patient. DELFLEX peritoneal dialysis solutions are available in the sizes and formulations shown in Table 2. Storage ConditionsStore at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (between 59°F and 86°F). See USP Controlled Room Temperature. Brief exposure to temperatures up to 40°C (104°F) may be tolerated provided the mean kinetic temperature does not exceed 25°C (77°F); however, such exposure should be minimized.Keep DEFLEX and all medicines out of the reach of children. Not for Intravenous Injection. Do not microwave.Warm solution as directed by your health care provider.DELFLEX peritoneal dialysis solutions are delivered in single-dose flexible bags. All DELFLEX peritoneal dialysis solutions have overfills declared on the bag label. The flexible bag has the capacity for drainage in excess of their stated fill volume for ultrafiltration from the patient. DELFLEX peritoneal dialysis solutions are available in the sizes and formulations shown in Table 2. Storage ConditionsStore at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (between 59°F and 86°F). See USP Controlled Room Temperature. Brief exposure to temperatures up to 40°C (104°F) may be tolerated provided the mean kinetic temperature does not exceed 25°C (77°F); however, such exposure should be minimized.Keep DEFLEX and all medicines out of the reach of children. Not for Intravenous Injection. Do not microwave.Warm solution as directed by your health care provider.DELFLEX peritoneal dialysis solutions are delivered in single-dose flexible bags. All DELFLEX peritoneal dialysis solutions have overfills declared on the bag label. The flexible bag has the capacity for drainage in excess of their stated fill volume for ultrafiltration from the patient. DELFLEX peritoneal dialysis solutions are available in the sizes and formulations shown in Table 2. Storage ConditionsStore at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (between 59°F and 86°F). See USP Controlled Room Temperature. Brief exposure to temperatures up to 40°C (104°F) may be tolerated provided the mean kinetic temperature does not exceed 25°C (77°F); however, such exposure should be minimized.Keep DEFLEX and all medicines out of the reach of children. Not for Intravenous Injection. Do not microwave.Warm solution as directed by your health care provider.DELFLEX peritoneal dialysis solutions are delivered in single-dose flexible bags. All DELFLEX peritoneal dialysis solutions have overfills declared on the bag label. The flexible bag has the capacity for drainage in excess of their stated fill volume for ultrafiltration from the patient. DELFLEX peritoneal dialysis solutions are available in the sizes and formulations shown in Table 2. Storage ConditionsStore at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (between 59°F and 86°F). See USP Controlled Room Temperature. Brief exposure to temperatures up to 40°C (104°F) may be tolerated provided the mean kinetic temperature does not exceed 25°C (77°F); however, such exposure should be minimized.Keep DEFLEX and all medicines out of the reach of children. Not for Intravenous Injection. Do not microwave.Warm solution as directed by your health care provider.DELFLEX peritoneal dialysis solutions are delivered in single-dose flexible bags. All DELFLEX peritoneal dialysis solutions have overfills declared on the bag label. The flexible bag has the capacity for drainage in excess of their stated fill volume for ultrafiltration from the patient. DELFLEX peritoneal dialysis solutions are available in the sizes and formulations shown in Table 2. Storage ConditionsStore at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (between 59°F and 86°F). See USP Controlled Room Temperature. Brief exposure to temperatures up to 40°C (104°F) may be tolerated provided the mean kinetic temperature does not exceed 25°C (77°F); however, such exposure should be minimized.Keep DEFLEX and all medicines out of the reach of children. Not for Intravenous Injection. Do not microwave.Warm solution as directed by your health care provider.DELFLEX peritoneal dialysis solutions are delivered in single-dose flexible bags. All DELFLEX peritoneal dialysis solutions have overfills declared on the bag label. The flexible bag has the capacity for drainage in excess of their stated fill volume for ultrafiltration from the patient. DELFLEX peritoneal dialysis solutions are available in the sizes and formulations shown in Table 2. Storage ConditionsStore at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (between 59°F and 86°F). See USP Controlled Room Temperature. Brief exposure to temperatures up to 40°C (104°F) may be tolerated provided the mean kinetic temperature does not exceed 25°C (77°F); however, such exposure should be minimized.Keep DEFLEX and all medicines out of the reach of children. Not for Intravenous Injection. Do not microwave.Warm solution as directed by your health care provider.DELFLEX peritoneal dialysis solutions are delivered in single-dose flexible bags. All DELFLEX peritoneal dialysis solutions have overfills declared on the bag label. The flexible bag has the capacity for drainage in excess of their stated fill volume for ultrafiltration from the patient. DELFLEX peritoneal dialysis solutions are available in the sizes and formulations shown in Table 2. Storage ConditionsStore at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (between 59°F and 86°F). See USP Controlled Room Temperature. Brief exposure to temperatures up to 40°C (104°F) may be tolerated provided the mean kinetic temperature does not exceed 25°C (77°F); however, such exposure should be minimized.Keep DEFLEX and all medicines out of the reach of children. Not for Intravenous Injection. Do not microwave.Warm solution as directed by your health care provider.
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Peritoneal dialysis is the process of filtering excess water and toxins from the bloodstream through a semi-permeable membrane. This process does not cure the disease, but prevents progression of symptoms. Dialysis for chronic kidney failure is essential to maintain life, unless the patient receives a kidney transplant. A peritoneal dialysis procedure utilizes the peritoneum (lining of the abdomen) as the semi-permeable membrane. The procedure is conducted by instilling peritoneal dialysis solution through a catheter in the abdomen into the peritoneal cavity. Since the peritoneum is heavily supplied with blood vessels, the contact of the solution with the peritoneum causes excess water and toxins in the bloodstream to be drawn across the membrane into the solution. This osmosis and diffusion occurs between the plasma of the patient and the peritoneal dialysis solution. After a period of time called "dwell time," the solution is then drained from the patient.
This solution does not contain potassium. In situations in which there is a normal serum potassium level or hypokalemia, the addition of potassium chloride (up to a concentration of 4 mEq/L) may be indicated to prevent severe hypokalemia.
Clinical studies have demonstrated that the use of low magnesium solutions resulted in significant increases in serum CO
and decreases in serum magnesium levels. The decrease in magnesium levels did not cause clinically significant hypomagnesemia.
Non-Clinical Toxicology
None known.Not for Intravenous Injection.
Use Aseptic Technique.
After removing the outerwrap, check for minute leaks by squeezing the solution bag firmly. If leaks are found, discard the solution because the sterility may be impaired. (A small amount of moisture may be present inside the outerwrap, which is normal condensation from the sterilization process).
Peritoneal dialysis should be done with great care, in patients with a number of conditions, including disruption of the peritoneal membrane or diaphragm by surgery or trauma, extensive adhesions, bowel distention, undiagnosed abdominal disease, abdominal wall infection, hernias or burns, fecal fistula or colostomy, tense ascites, obesity, large polycystic kidneys, recent aortic graft replacement, lactic acidosis and severe pulmonary disease. When assessing peritoneal dialysis as the mode of therapy in such extreme situations, the benefits to the patient must be weighed against the possible complications.
Solutions containing lactate ion should be used with great care in patients with metabolic or respiratory alkalosis. Lactate should be administered with great care in those conditions in which there is an increased level or an impaired utilization of this ion, such as severe hepatic insufficiency.
An accurate fluid balance record must be kept and the weight of the patient carefully monitored to avoid over or under hydration with severe consequences, including congestive heart failure, volume depletion and shock.
Excessive use of DELFLEX peritoneal dialysis solution with 4.25% dextrose during a peritoneal dialysis treatment can result in significant removal of water from the patient.
Stable patients undergoing maintenance peritoneal dialysis should have routine periodic evaluation of blood chemistries and hematologic factors, as well as other indicators of patient status.
Serum calcium levels in patients using low calcium concentrations should be monitored and if found to be low, the peritoneal solution in use should be altered to one with a higher calcium concentration.
Nonsteroidal anti-inflammatory drugs should not be administered prior to or concomitantly with the high doses of methotrexate, such as used in the treatment of osteosarcoma. Concomitant administration of some NSAIDs with high dose methotrexate therapy has been reported to elevate and prolong serum methotrexate levels, resulting in deaths from severe hematologic and gastrointestinal toxicity.
Caution should be used when NSAIDs and salicylates are administered concomitantly with lower doses of methotrexate. These drugs have been reported to reduce the tubular secretion of methotrexate in an animal model and may enhance its toxicity.
Despite the potential interactions, studies of methotrexate in patients with rheumatoid arthritis have usually included concurrent use of constant dosage regimens of NSAIDs, without apparent problems. It should be appreciated, however, that the doses used in rheumatoid arthritis (7.5 to 15 mg/week) are somewhat lower than those used in psoriasis and that larger doses could lead to unexpected toxicity.
Methotrexate is partially bound to serum albumin, and toxicity may be increased because of displacement by certain drugs, such as salicylates, phenylbutazone, phenytoin, and sulfonamides. Renal tubular transport is also diminished by probenecid; use of methotrexate with this drug should be carefully monitored.
In the treatment of patients with osteosarcoma, caution must be exercised if high-dose methotrexate is administered in combination with a potentially nephrotoxic chemotherapeutic agent (e.g., cisplatin).
Methotrexate increases the plasma levels of mercaptopurine. The combination of methotrexate and mercaptopurine may therefore require dose adjustment.
Oral antibiotics such as tetracycline, chloramphenicol, and nonabsorbable broad spectrum antibiotics, may decrease intestinal absorption of methotrexate or interfere with the enterohepatic circulation by inhibiting bowel flora and suppressing metabolism of the drug by bacteria.
Penicillins may reduce the renal clearance of methotrexate; increased serum concentrations of methotrexate with concomitant hematologic and gastrointestinal toxicity have been observed with high and low dose methotrexate. Use of methotrexate with penicillins should be carefully monitored.
The potential for increased hepatotoxicity when methotrexate is administered with other hepatotoxic agents has not been evaluated. However, hepatotoxicity has been reported in such cases. Therefore, patients receiving concomitant therapy with methotrexate and other potential hepatotoxins (e.g., azathioprine, retinoids, sulfasalazine) should be closely monitored for possible increased risk of hepatotoxicity.
Methotrexate may decrease the clearance of theophylline; theophylline levels should be monitored when used concurrently with methotrexate.
Vitamin preparations containing folic acid or its derivatives may decrease responses to systemically administered methotrexate. Preliminary animal and human studies have shown that small quantities of intravenously administered leucovorin enter the CSF primarily as 5-methyltetrahydrofolate and, in humans, remain 1 to 3 orders of magnitude lower than the usual methotrexate concentrations following intrathecal administration. However, high doses of leucovorin may reduce the efficacy of intrathecally administered
methotrexate.
Folate deficiency states may increase methotrexate toxicity. Trimethoprim/ sulfamethoxazole has been reported rarely to increase bone marrow suppression in patients receiving methotrexate, probably by decreased tubular secretion and/or an additive antifolate effect.
General
Chronic patients that have been stabilized on peritoneal dialysis therapy should have routine evaluation of electrolyte blood chemistries and hematologic factors measured in order to determine the patient's ongoing condition.
DEFLEX peritoneal dialysis solutions do not include potassium. Potassium chloride should only be added under the direction of a physician after careful evaluation of both serum and total body potassium.
Significant loss of protein, amino acids and water soluble vitamins may occur during peritoneal dialysis. Replacement therapy should be provided as necessary.
Information for Patients
Aseptic technique must be used throughout the procedure and at its termination in order to reduce the possibility of infection.
The outerwrap should remain intact until time of use.
Administer only if the solution is clear, all seals are intact, and there is no evidence of leaking.
Do not heat in a microwave oven. Microwave ovens heat unevenly and can leave hot spots, which can burn the peritoneum.
Care should be taken to ensure that there is not any leakage around the catheter, since if not controlled, the leakage can create edema from subcutaneous infiltration of the dialysis solution. The leakage will also create an inaccurate fluid balance measurement. If any leakage is identified do not proceed with infusion and notify your physician.
Laboratory Tests
Serum electrolytes, magnesium, bicarbonate levels and fluid balance should be periodically monitored.
Carcinogenesis, Mutagenesis, Impairment of Fertility
Long term animal studies with DELFLEX peritoneal dialysis solutions have not been performed to evaluate the carcinogenic potential, mutagenic potential or effect on fertility.
Pregnancy: Teratology Effects
Pregnancy Category C. Animal reproduction studies have not been conducted with DELFLEX peritoneal dialysis solutions. It is also not known whether DELFLEX peritoneal dialysis solutions can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. DELFLEX peritoneal dialysis solutions should be given to a pregnant woman only if clearly needed.
Nursing Mothers
Caution should be exercised when DELFLEX peritoneal dialysis solutions are administered to a nursing woman.
Pediatric Use
Safety and effectiveness in pediatric patients have not been established.
Adverse reactions occurring with administration of peritoneal dialysis include mechanical and solution related problems as well as the results of contamination of equipment or improper technique in catheter placement. Abdominal pain, bleeding, peritonitis, subcutaneous infection around a peritoneal catheter, catheter blockage, difficulty in fluid removal, and ileus are among the complications of the procedure. Solution related adverse reactions may include peritonitis, catheter site infection, electrolyte and fluid imbalances, hypovolemia, hypervolemia, hypertension, hypotension, disequilibrium syndrome and muscle cramping.
If an adverse reaction does occur, institute appropriate therapeutic procedures according to the patient's needs and conditions, and save the remainder of the fluid in the bag for evaluation if deemed necessary.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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